BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA CERAMIC FEM HD 36/0MM

    MDR report key: 19581875 · Received June 21, 2024

    Report

    Report Number
    3002806535-2024-00228
    Event Type
    Injury
    Date Received
    June 21, 2024
    Date of Event
    May 27, 2024
    Report Date
    August 23, 2024
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271175
    PMA / PMN Number
    K200959
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) D10 - ASSOCIATED MEDICAL DEVICES: 58MM O.D. SIZE LL POROUS UNCEMENTED WITH CLUSTER HOLES SHELL; ITEM# 00875705801; LOT# 63640013 BONE SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH; ITEM# 00625006530; LOT# 63535924 BONE SCREW SELF-TAPPING 6.5 MM DIA. 40 MM LENGTH; ITEM# 00625006540; LOT# 63214016 ARCOS 16X150MM SPL TPR DIST; ITEM# 11-300816; LOT# 124690 ARCOS CON SZ D STD 60MM; ITEM# 11-301304; LOT# 213170 BIOLOX DELTA CERAMIC TAPER LINER, SIZE LL / 36 I.D; 00877501336; LOT# 2738375 G2 - FOREIGN: AUSTRALIA THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED A CERAMIC HEAD WITH WHAT APPEARS TO BE METAL TRANSFER MARKS ON THE ARTICULATING SURFACE. IT IS LIKELY THAT THE MARKS WERE CAUSED UPON REMOVAL OF THE HEAD DURING REVISION SURGERY AS THE PICTURE OF THE MATING CERAMIC LINER DOES NOT HAVE A CORRESPONDING METAL TRANSFER PATTERN. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. ONE X-RAY PICTURE WAS PROVIDED AND REVIEWED BY A RADIOLOGIST. ASSESSMENT OF IMAGING: RIGHT HIP ARTHROPLASTY COMPONENTS ARE ANATOMICALLY ALIGNED. THERE IS NO ACUTE OSSEOUS ABNORMALITY. THE DEVICE HAS NOT BEEN RETURNED THEREFORE THE CONDITION OF THE COMPONENT REMAINS UNKNOWN. PATIENT FACTORS THAT MAY HAVE AFFECTED THE PERFORMANCE OF THE COMPONENTS SUCH AS ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. IF AND TO WHAT EXTENT OTHER POSSIBLE FACTORS MIGHT HAVE BEEN INVOLVED ALSO REMAINS UNKNOWN. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY SIX YEARS AND SIX MONTHS LATER DUE TO POOR ALIGNMENT OF THE ACETABULAR COMPONENT. THERE WAS REPRODUCIBLE AUDIBLE SQUEAKING AND CREPITUS BY THE PATIENT. IT WAS INDICATED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284714 BIOLOX DELTA CERAMIC FEM HD 36/0MM HIP PROSTHESIS LZO BIOMET UK LTD. 2017050061 00887868271175

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H SEE H11 NARRATIVE.